1. Field of the Invention
The present invention pertains to a packaging system for a patient interface device, such as a respiratory mask, and, in particular, to a packaging system where the packaging containing the respiratory mask includes an integrated sizing gage for use in determining whether the mask contained in that package is a proper fit for a user.
2. Description of the Related Art
A variety of respiratory masks or patient interface devices are known that have flexible seals and cover the nose, mouth, or both of a human user and are designed to create a seal against the user's face. Because of the sealing effect that is created, gases can be provided at a positive pressure within the mask for consumption by the user. Uses for such masks range from high altitude breathing, i.e. aviation applications, to mining and fire fighting applications, to various medical diagnostic and therapeutic applications. For example, such masks are used to delivery continuous positive airway pressure (CPAP) or variable airway pressure, which varies with the patient's respiratory cycle, to an airway of a patient. This is done to treat a medical disorder, such as sleep apnea syndrome, in particular, obstructive sleep apnea (OSA), or congestive heart failure or to ventilate a patient who has a compromised respiratory ability.
A requisite of such respiratory masks is that they provide an effective seal against the user's face to prevent leakage of the gas being supplied. Commonly, in prior mask configurations, a good mask-to-face seal has been attained in many instances only with considerable discomfort to the user. This problem is most crucial because such masks are typically worn for an extended period of time. One concern in such a situation is that a user may avoid wearing an uncomfortable mask, defeating the purpose of the prescribed pressure support therapy.
Thus, to ensure a comfortable fit providing an adequate seal, it is important that the mask fit a patient's face properly. Typically, respiratory masks are provided in a range of sizes, such as “small”, “medium” and “large”, or “adult” and “child”. Traditionally, the product's manufacture supplies a sizing gage, also referred to as a template, for use in determining which size is best suited for each user. The sizing template is typically formed from a rigid material with a plurality of cutouts, each cutout corresponding to a different size of the mask. The user places the template on the part of the body to be measured, such as over the nose and/or mouth, to determine which the size mask best fits their anatomical features. The user can test their anatomical features in each different size cutout determine which cutout, and, hence, which size mask, best matches their features.
This template must be available to the provider each time a patient is sized. A disadvantage to this system is the provider must remember to take a sizing gage with them to a patient's residence, in the case of a homecare application, or to the patient's bedside, in the case of a hospital application. It should be apparent that one disadvantage, is that this rigid gage may not always be available.
In another sizing technique, “eyeballing” is used. In this instance, the provider will guess the appropriate size product for the patient. It should be apparent that this method can easily result in the selection of the wrong product size. In another sizing procedure, the mask packaging is opened and the product is tried on the patient. If the mask is not the correct size, the mask must be cleaned and disinfected prior to use on the next patient, or the mask may be disposed. Disposing of unused product is obviously wasteful and not profitable. Cleaning and/or disinfecting product is time consuming and may require special equipment or chemicals to properly clean the product.
Thus, an advantage exists to provide a sizing gage with every product, eliminating the need to carry a durable gage or many different gages to suit the broad range of products available. Guessing at mask sizes would also be eliminated, as a sizing gage would be readily available. Providers would no longer be required to open products that would ultimately not be used on the patient. The potential disposal of unused product and the need for disinfection equipment and chemicals would be eliminated.